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ECTNCT06062758

The Efficiency of Simulation-Based Electroconvulsive Therapy Training

A study testing ECT Simulation Training in people with ECT and Mental Disorder, run by Fenerbahce University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this study is to determine the effect of the simulation-based Electroconvulsive Therapy (ECT) Simulation Training applied to senior nursing students studying at a foundation university on students' perceptions and knowledge levels about ECT. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
ECT, Mental Disorder, Nursing Caries
What is being tested?
ECT Simulation Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Oct 2023to 3 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Being a fourth-year student of Fenerbahçe University Faculty of Health Sciences, Department of Nursing, Turkish Nursing Program,
  • To be enrolled in Psychiatric and Mental Health course,
  • Volunteering to participate in the study.

Who cannot join

  • Being a student of Fenerbahçe University, Faculty of Health Sciences, Department of Nursing, Turkish Nursing Program, but not enrolled in the Mental Health and Diseases course,
  • Not participating in simulation training,
  • Incomplete completion of data collection tools,
  • Not volunteering to participate in the study.

Trial locations and contacts

1 site in 1 country.

Gul Dikeç, Assoc. Prof. contact

+905303884860

gul.dikec@fbu.edu.tr

Turkey (Türkiye)1 site
  • Fenerbahce University

    Istanbul, 34758

    Arzu Harmancı Seren, Prof., +0216 910 1907, arzu.seren@fbu.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Simulation-Based Electroconvulsive Therapy Training on Perception and Knowledge of Nursing Students: A Semi-Experimental Study

The goal of this study is to determine the effect of the simulation-based Electroconvulsive Therapy (ECT) Simulation Training applied to senior nursing students studying at a foundation university on students' perceptions and knowledge levels about ECT.

The research hypotheses are as follows; H0: There is no significant difference between students' perception and knowledge levels about ECT before and after simulation-based ECT training to be applied to nursing students.

Read more

H1: There is a significant difference between students' perception and knowledge levels about ECT before and after the simulation-based ECT training to be applied to nursing students.

Type of study: This study was planned in a single group pre-test post-test quasi-experimental design.

Participants: The study population will consist of fourth-year students (n=72) of Fenerbahçe University Faculty of Health Sciences, Department of Nursing, Turkish Nursing Program.

Intervention: The study will collect data before the students start clinical practice and before the theoretical course on Electroconvulsive Therapy. Then, a one-hour theoretical training on electroconvulsive therapy will be given. This training includes ECT, its history, use areas, nursing care before, during and after ECT and patient education. After the theoretical lecture, a simulation scenario will be distributed to the students, and they will be asked to come prepared on the simulation day. Students will be divided into groups of 15 people, and the groups will be met in the Simulation Laboratory at the determined group hours.

Control Group: There is no control group. Outcome: Perceptions and knowledge levels about ECT.

Read the detailed description

Aim This study aimed to determine the effect of the simulation-based Electroconvulsive Therapy Simulation Training applied to senior nursing students studying at a foundation university on students' perceptions and knowledge levels about ECT.

Study Design This study was planned in a single group pre-test post-test quasi-experimental design.

Hypotheses The research hypotheses are as follows; H0: There is no significant difference between students' perception and knowledge levels about ECT before and after simulation-based ECT training to be applied to nursing students.

H1: There is a significant difference between students' perception and knowledge levels about ECT before and after the simulation-based ECT training to be applied to nursing students.

Varıables Of The Study The study's dependent variable is the level of perception and knowledge about ECT, and the independent variable is ECT simulation training.

Settings The research is aimed to be implemented between 01.10.2023 05.01.2024 between 01.10.2023-and 01.01.2024 within the scope of the Psychiatric and Mental Health Nursing course and in the Simulation Laboratory of Fenerbahçe University, Faculty of Health Sciences, Department of Nursing, Turkish Nursing Program senior students.

Participants The study population will consist of fourth-year students (n=72) of Fenerbahçe University Faculty of Health Sciences, Department of Nursing, Turkish Nursing Program. Sampling calculation and sample selection will not be made in the study, aiming to reach the entire population.

Inclusion Criteria:

  • Being a fourth-year student of Fenerbahçe University Faculty of Health Sciences, Department of Nursing, Turkish Nursing Program,
  • To be enrolled in Mental Health and Diseases course,
  • Volunteering to participate in the study.

Exclusion Criteria:

  • Being a student of Fenerbahçe University, Faculty of Health Sciences, Department of Nursing, Turkish Nursing Program, but not enrolled in the Mental Health and Diseases course,
  • Not participating in simulation training,
  • Incomplete completion of data collection tools,
  • Not volunteering to participate in the study. Measurements Data will be collected with the Information Form and the Perception and Knowledge Scale about ECT.

Information Form: The researcher prepared this form, consisting of questions about the students' sociodemographic characteristics and their familiarity with mental disorders and ECT.

Perception and Knowledge Scale about ECT: It was developed by Tsai et al. to determine knowledge and attitudes about ECT. It consists of 18 items in total. The subscale for perceptions about electroconvulsive therapy includes six items on a five-point Likert scale scored between 1 (strongly disagree) and 5 (strongly agree), and the subscale for knowledge about ECT includes 12 yes-no items. Total scale score changes between 12 and 60. Higher perception and knowledge subscale scores mean a better perception and higher level of knowledge. The Turkish validity and reliability of the scale was performed by Yıldırım et al. (2023). The Cronbach's alpha coefficient was 0.85 for the perception subscale and 0.78 for the knowledge subscale. Permission to use the scale was obtained from Dr. Yıldırım via e-mail.

Data Collection The study will collect data before the students start clinical practice and before the theoretical course on Electroconvulsive therapy. Then, a one-hour theoretical training on electroconvulsive therapy will be given. This training includes ECT, its history, use areas, nursing care before, during, and after ECT, and patient education. After the theoretical lecture, a simulation scenario will be distributed to the students, and they will be asked to come prepared on the simulation day. Students will be divided into groups of 15 people, and the groups will be met in the Simulation Laboratory at the determined group hours.

The coding method will match the students' pre-test, post-test, and follow-up scores. Students will be asked to code the codes consisting of the first letter of their surname, the last two digits of their date of birth, and their lucky numbers on the first page of the pre-test. They will be asked to repeat this coding in the post-test and follow-up.

The pre-test will apply the information Form and Perception and Knowledge Scale about ECT. Then, theoretical training and simulation training will be applied. Students will be asked to fill in the Perception and Knowledge Scale about ECT in the post-test (after two weeks of pre-test). Finally, a follow-up test will be conducted after the students complete the mental health and diseases nursing course and clinical practice (after three months later pre-test).

ECT Simulation Training ECT Simulation training prepared by the researcher consists of instructor and student scenarios. The faculty member scenario includes simulation learning objectives, detailed information about the case, possible facilitating patient and student questions and answers during the simulation, and an evaluation form. The student scenario includes simulation objectives, information about the case and roles, and an evaluation form.

Simulation training will consist of three stages. The first stage is preliminary preparation. At this stage, students who review the resources identified and come prepared for the simulation scenario will be asked questions appropriate to the simulation objectives to help them remember the subject. Then, four students will be selected from the groups and given their roles. In the second stage, the simulation will be realized. A high-fidelity mannequin/simulator will be used during the simulation, and the responsible faculty member and researcher will give patient responses in the cabin. While the students taking roles during the simulation provide care to the patient, other group members will watch their teammates in the cabin or in a classroom where a camera is provided. The third stage is the debriefing stage. At this stage, three evaluations will be made. First, the self-evaluation of the students who took part in the simulation, then the evaluation of the students by their groupmates, and finally, the evaluation of the faculty member will be shared. The simulation will be finalized by discussing the critical points of the case, the care to be given, communication skills and patient safety.

Data Analysis The data obtained in the study will be analyzed using SPSS (Statistical Package for Social Sciences) for the Windows 26.0 program. The data will be analyzed by number, percentage distributions, mean and standard deviation. Kurtosis and Skewness will be used to evaluate whether the scale scores are normally distributed, and paired t-tests or Wilcoxon signed-rank tests will be used to compare the pre-test and post-test scores. All data will be tested for significance at p<0.05 level.

Funding No expenditure will be made on any item other than the consumables of the existing forms for the research. The researcher will cover stationery and consumables.

In addition, the simulator (high fidelity mannequin) in the simulation laboratory of Fenerbahçe University Faculty of Health Sciences, Department of Nursing will be used within the scope of the study by obtaining the necessary permissions.

Being tested
ECT Simulation Training
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ECT Simulation TrainingBehavioural

    Simulation training will consist of three stages. The first stage is preliminary preparation. At this stage, students who review the resources identified and come prepared for the simulation scenario will be asked questions appropriate to the simulation objectives to help them remember the subject. In the second stage, the simulation will be realized. A high-fidelity mannequin/simulator will be used during the simulation, and the responsible faculty will give patient responses in the cabin. While the students taking roles during the simulation provide care to the patient, other group members will watch their teammates in the cabin or in a The simulation will be finalized by discussing the critical points of the case, the care to be given, communication skills and patient safety.

Study groups in NCT06062758
Study groupRoleWhat they receive
Nursing StudentsExperimentalThe study population will consist of fourth-year students (n=72) of Fenerbahçe University Faculty of Health Sciences, Department of Nursing, Turkish Nursing Program. Sampling calculation and sample selection will not be made in the study, aiming to reach the entire population.
Receives: Behavioral: ECT Simulation Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perception and Knowledge about ECT

    Perception and Knowledge Scale about ECT

    Measured: Pre-test (before the intervention), post-test (two weeks after intervention) and three months after follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2023
  2. Study start2 Oct 2023 (estimated)
  3. Primary completion18 Oct 2023 (estimated)
  4. Study completion3 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Simulation training will consist of three stages. The first stage is preliminary preparation. At this stage, students who review the resources identified and come prepared for the simulation scenario will be asked questions appropriate to the simulation objectives to help them remember the subject. In the second stage, the simulation will be realized. A high-fidelity mannequin/simulator will be used during the simulation, and the responsible faculty will give patient responses in the cabin. While the students taking roles during the simulation provide care to the patient, other group members will watch their teammates in the cabin or in a The simulation will be finalized by discussing the critical points of the case, the care to be given, communication skills and patient safety.
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06062758
Sponsor's protocol ID
Fenerbahce University
Status last verified
Sep 2023
First submitted
14 Sep 2023
Last updated
2 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The coding method will match the students' pre-test, post-test and follow-up scores. Students will be asked to code the codes consisting of the first letter of their surname, the last two digits of their date of birth, and their lucky numbers on the first page of the pre-test. They will be asked to repeat this coding in the post-test and follow-up.

Publications

  • Dikec G, San EO. The Effect of Simulation-Based Electroconvulsive Therapy Education on Perception and Knowledge of Nursing Students: A Semiexperimental Study. J ECT. 2026 Mar 1;42(1):46-50. doi: 10.1097/YCT.0000000000001130. Epub 2026 Feb 25.

    PubMed 40020048

Questions about this trial

What is this clinical trial studying?

A study testing ECT Simulation Training in people with ECT and Mental Disorder, run by Fenerbahce University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gul Dikeç, Assoc. Prof. (+905303884860, gul.dikec@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perception and Knowledge about ECT (time frame: Pre-test (before the intervention), post-test (two weeks after intervention) and three months after follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06062758, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.

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